We are seeking a highly motivated and experienced Associate Director of Toxicology (Nonclinical Safety) to support the advancement of our pipeline programs. This individual will play a key role in designing, executing, and interpreting nonclinical safety strategies across discovery and development programs. This role will contribute to research and development programs.
The successful candidate will serve as a subject matter expert on cross-functional teams and contribute to regulatory strategy, ensuring that nonclinical programs are scientifically robust and aligned with development timelines.
Key Responsibilities:
Nonclinical Strategy & Leadership
- Serve as the nonclinical safety/toxicology subject matter expert on multidisciplinary project teams
- Provide integrated assessments of nonclinical data and evaluate overall risk/benefit profiles
- Contribute to development candidate selection and overall program strategy
Study Design & Execution
- Design, oversee, and monitor nonclinical safety studies, including:
- Exploratory/non-GLP toxicology studies
- IND-enabling toxicology and safety pharmacology studies
- Post-IND studies (e.g., sub-chronic, chronic, reproductive, carcinogenicity)
- Manage and oversee CROs and external vendors, including study design, execution, and data quality
Data Analysis & Interpretation
- Analyze and interpret nonclinical study data to support program decisions
- Prepare and present findings, and provide guidance to internal stakeholders and governance teams
- Identify data gaps and proactively develop mitigation strategies
Regulatory Support
- Author and review nonclinical sections of regulatory documents, including:
- INDs
- Investigator's Brochures (IBs)
- Briefing books and responses to health authorities
- Partner with Regulatory Affairs to support interactions with agencies (e.g., FDA)
- Ensure compliance with GLP, ICH, and applicable regulatory guidelines
Cross-Functional Collaboration
- Work closely with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams
- Contribute to integrated development plans and timelines
- Support portfolio-level decision-making through scientific insight
Qualifications
Education & Experience
- PhD in Toxicology, Pharmacology, or related scientific discipline
- DABT board certification is preferred
- ~10+ years of industry experience in nonclinical safety/toxicology
- Experience supporting small molecule drug development programs preferred
- Experience with IND-enabling and regulatory toxicology strategies required
Core Competencies
- Strong scientific judgment and problem-solving capabilities
- Excellent communication and presentation skills
- Ability to work effectively in cross-functional, fast-paced environments
- Collaborative, proactive, and detail-oriented mindset
Technical Skills
- Strong knowledge of GLP regulations, ICH guidance, and regulatory expectations
- Experience designing, monitoring, and interpreting nonclinical safety studies
- Familiarity with CRO oversight and external vendor management
Preferred Qualifications
- Experience supporting regulatory submissions and agency interactions
- Background in pain, neuroscience, or related therapeutic areas
- Prior experience in early-stage biotech environments
